[Federal Register Volume 82, Number 138 (Thursday, July 20, 2017)]
[Notices]
[Pages 33505-33507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15204]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-3857]


Enhanced Drug Distribution Security Under the Drug Supply Chain 
Security Act; Public Meetings; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meetings; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing three public meetings entitled ``Enhanced Drug Distribution 
Security Under the Drug Supply Chain Security Act (DSCSA).'' These 
public meetings are intended to provide members of the pharmaceutical 
distribution supply chain and other interested stakeholders an 
opportunity to discuss with FDA, and provide input on, strategies and 
issues related to the enhanced drug distribution security provisions of 
the DSCSA.

DATES: The public meetings will be held on: August 23, 2017, from 9 
a.m. to 4 p.m.; December 5 and 6, 2017, from 9 a.m. to 4 p.m.; and 
February 28, 2018, from 9 a.m. to 4 p.m.

ADDRESSES: The public meetings will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31, Rm. 1503A, Silver Spring, MD 20993. 
Entrance for the public meeting participants (non-FDA employees) is 
through Building 1 where routine security check procedures will be 
performed. For parking and security information, please refer to 
https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Comments: To permit the widest possible opportunity to obtain 
public comment, FDA is soliciting either electronic or written comments 
on all aspects of the public meeting topics. You may submit comments as 
follows. Please note that the deadlines for submitting either 
electronic or written comments are 30 days after the meeting to which 
the comments relate. Comments received by mail/hand delivery/courier 
(for written/paper

[[Page 33506]]

submissions) will be considered timely if they are postmarked or the 
delivery service acceptance receipt is on or before that date. The 
https://www.regulations.gov electronic filing system will accept 
comments until midnight Eastern Time at the end of the specified date. 
See the SUPPLEMENTARY INFORMATION section for registration dates and 
for the deadlines for submitting electronic or written comments related 
to these public meetings (table 1).

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-N-3857 for ``Enhanced Drug Distribution Security Under the 
Drug Supply Chain Security Act; Public Meetings; Request for 
Comments.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Daniel Bellingham, Office of 
Compliance, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-3130, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) 
(Title II, Pub. L. 113-54) was signed into law. The DSCSA outlines 
critical steps to build an electronic, interoperable system by 2023 to 
identify and trace certain prescription drugs as they are distributed 
within the United States. This system will enhance FDA's ability to 
protect U.S. consumers from exposure to drugs that may be counterfeit, 
diverted, stolen, intentionally adulterated, or otherwise harmful by 
improving the detection and removal of potentially dangerous drugs from 
the drug supply chain. Section 582(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360eee-1(i)), which was added by the DSCSA, 
directs FDA to hold public meetings to enhance the safety and security 
of the pharmaceutical distribution supply chain and provide 
opportunities for comment from stakeholders.

II. Purpose of the Public Meetings

    FDA will hold public meetings on August 23, 2017, December 5 and 6, 
2017, and February 28, 2018, on enhanced drug distribution security. 
The purpose of these public meetings is to provide members of the 
pharmaceutical distribution supply chain and other interested 
stakeholders an opportunity to discuss with FDA, and provide input on, 
strategies and issues related to the enhanced drug distribution 
security provisions of the DSCSA. These public meetings will focus on 
the following topics for discussion:

 What supply chain security should look like in 2023
 What is needed for enhanced drug distribution security
 What is needed for electronic interoperability
 Standards for product tracing
 Data architecture options for an electronic interoperable 
system
 The management and maintenance of product tracing data
 The use of aggregation and inference for enhanced product 
tracing and verification
 Building capacity for a unit-level system for product tracing 
and verification

    FDA may include additional discussion topics. Materials for each 
public meeting will be provided on FDA's Web site at https://www.fda.gov/Drugs/NewsEvents/UCM559090.htm 10 days before each public 
meeting.

III. Registration for the Public Meetings

    To request registration for the public meetings, provide your 
information including name, company or organization, address, telephone 
number, and email address to FDA at

[[Page 33507]]

https://www.fda.gov/Drugs/NewsEvents/UCM559090.htm. Registration 
requests for each meeting should be received during the time periods 
specified in table 1. FDA is limiting attendance due to restricted 
space. In addition, FDA may limit the number of participants from each 
organization based on space limitations. FDA recommends that each 
organization determine who should register for the public meeting to 
represent his/her organization. This will help ensure that the meeting 
will have broad and varied representation, including across the 
pharmaceutical distribution supply chain. Registrants will receive 
confirmation of participation for their chosen meeting from FDA within 
14 days of the date of each meeting. There is no registration fee for 
the public meetings. There will be no onsite registration. If 
registration reaches maximum capacity, FDA will post a notice closing 
registration for the meeting on FDA's Web site at https://www.fda.gov/Drugs/NewsEvents/UCM559090.htm. If you need special accommodations due 
to a disability, please contact Daniel Bellingham (see FOR FURTHER 
INFORMATION CONTACT) at least 7 days in advance of the public meeting.

                                       Table 1--Public Meeting Information
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                                                                                           Relevant section of
            Public meeting                      Topics                 Date/Time             this document or
                                                                                            electronic address
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# 1..................................   Supply chain    August 23, 2017, 9 a.m.
                                        security in 2023.        to 4 p.m.
                                        Enhanced drug
                                        distribution security
                                        needs.
                                       Advance registration...  by July 31, 2017.......  Online registration
                                                                                          only at https://www.fda.gov/Drugs/NewsEvents/UCM559090.htm. No
                                                                                          onsite registration.
                                       Comment period closes..  September 22, 2017.....  See ``Comments''.
                                       Request special          by August 16, 2017.....  See FOR FURTHER
                                        accommodations due to                             INFORMATION CONTACT.
                                        a disability.
# 2..................................   Electronic      December 5-6, 2017, 9
                                        interoperability.        a.m. to 4 p.m.
                                        Standards for
                                        data exchange.
                                        Data
                                        architecture.
                                        Aggregation
                                        and inference.
                                       Advance registration...  October 2-27, 2017.....  Online registration
                                                                                          only at https://www.fda.gov/Drugs/NewsEvents/UCM559090.htm. No
                                                                                          onsite registration.
                                       Comment period closes..  January 5, 2018........  See ``Comments''.
                                       Request special          by November 28, 2017...  See FOR FURTHER
                                        accommodations due to                             INFORMATION CONTACT.
                                        a disability.
# 3..................................   Further         February 28, 2018, 9
                                        refinement of enhanced   a.m. to 4 p.m.
                                        drug distribution
                                        security needs.
                                        Building
                                        capacity for a unit-
                                        level system.
                                       Advance registration...  January 2-26, 2018.....  Online registration
                                                                                          only at https://www.fda.gov/Drugs/NewsEvents/UCM559090.htm. No
                                                                                          onsite registration.
                                       Comment period closes..  March 30, 2018.........  See ``Comments''.
                                       Request special          by February 21, 2018...  See FOR FURTHER
                                        accommodations due to                             INFORMATION CONTACT.
                                        a disability.
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IV. Webcasting of the Public Meeting

    Portions of each public meeting will be recorded and webcast on the 
day of the meeting. Information for how to access the webcast will be 
available at https://www.fda.gov/Drugs/NewsEvents/UCM559090.htm within 
7 days prior to each public meeting. The webcast will be conducted in 
listening mode only.

    Dated: July 14, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15204 Filed 7-19-17; 8:45 am]
 BILLING CODE 4164-01-P